PMID- 26083953 OWN - NLM STAT- MEDLINE DCOM- 20160620 LR - 20221207 IS - 2164-554X (Electronic) IS - 2164-5515 (Print) IS - 2164-5515 (Linking) VI - 11 IP - 10 DP - 2015 TI - Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial. PG - 2425-33 LID - 10.1080/21645515.2015.1055429 [doi] AB - Streptococcus pneumoniae is an important pathogen causing invasive diseases such as sepsis, meningitis, and pneumonia. Vaccines have become the most effective way to prevent pneumococcal infections. This phase III trial was designed to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years. We conducted a randomized, double-blinded, active-controlled, multicenter trial in which 1660 healthy population (>2 years of age) were randomly assigned in a 1 : 1 ratio to receive 2 intramuscular doses of either the treatment vaccine or the active control vaccine, PNEUMOVAX 23. The surveillance period was 30 days. The primary end point was the 2-fold increase rate of anti-pneumococcal antibody for all 23 included serotypes in each group. In the intention-to-treat cohort, the 2-fold increase rate of anti-pneumococcal antibody for 23 included serotypes varied from 62.47% to 97.01% in the treatment group, and from 51.49% to 95.77% in the control group. According to -10% non-inferiority margin and 95% confidence intervals of rate difference, almost all included serotypes of the treatment group reached non-inferiority to control group except for serotype 6B, the lower limit of rate difference of which was -10.00%, equal to the non-inferiority margin. The 2-fold increase rates of anti-pneumococcal antibody were significantly higher in the treatment group for serotype 2, 3, 4, 10A, 11A and 20. Furthermore, for all 23 serotypes, IgG geometric mean concentrations (GMCs) at day 30 were significantly higher in treatment group for serotype 2, 3, 4, 9 V, 10A, 11A, 15 B, 18C, 19 A, 22 F and 33 F. Higher geometric mean fold increase (GMFI) were also observed in the treatment group correspondingly. Serious adverse events occurred in 3 of 830 participants in the treatment group (0.36%) and 2 of 830 participants in the control group (0.24%). No death occurred during the trial. The frequencies of both solicited and unsolicited adverse events (AEs) were small lower in the treatment group (34.34% vs 35.66% for solicited AEs, 4.34% vs 5.42% for unsolicited AEs). Both vaccines were well tolerated and most AEs were mild or moderate in intensity. The newly vaccine was well tolerated and immunologically non-inferior to the active control vaccine PNEUMOVAX 23 for all 23 vaccine serotypes in the Chinese population (>2 years of age). FAU - Kong, Yujia AU - Kong Y AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. FAU - Zhang, Wei AU - Zhang W AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. FAU - Jiang, Zhiwei AU - Jiang Z AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. FAU - Wang, Ling AU - Wang L AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. FAU - Li, Chanjuan AU - Li C AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. FAU - Li, Yanping AU - Li Y AD - b Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous Region ; Nanning , China. FAU - Xia, Jielai AU - Xia J AD - a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Hum Vaccin Immunother JT - Human vaccines & immunotherapeutics JID - 101572652 RN - 0 (23-valent pneumococcal capsular polysaccharide vaccine) RN - 0 (Antibodies, Bacterial) RN - 0 (Pneumococcal Vaccines) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Bacterial/*blood MH - Asian People MH - Child MH - Child, Preschool MH - Double-Blind Method MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology MH - Female MH - Healthy Volunteers MH - Humans MH - Injections, Intramuscular MH - Male MH - Middle Aged MH - Pneumococcal Vaccines/administration & dosage/*adverse effects/*immunology MH - Streptococcal Infections/*prevention & control MH - Treatment Outcome MH - Young Adult PMC - PMC4635697 OTO - NOTNLM OT - immunogenicity OT - pneumococcal polysaccharide vaccine OT - safety EDAT- 2015/06/18 06:00 MHDA- 2016/06/21 06:00 PMCR- 2016/06/17 CRDT- 2015/06/18 06:00 PHST- 2015/06/18 06:00 [entrez] PHST- 2015/06/18 06:00 [pubmed] PHST- 2016/06/21 06:00 [medline] PHST- 2016/06/17 00:00 [pmc-release] AID - 1055429 [pii] AID - 10.1080/21645515.2015.1055429 [doi] PST - ppublish SO - Hum Vaccin Immunother. 2015;11(10):2425-33. doi: 10.1080/21645515.2015.1055429.